Cleared Traditional

K861683 - MONSANTO SANTOPRENE (PERITONE DEVICE)

K861683 is an FDA 510(k) clearance for MONSANTO SANTOPRENE (PERITONE DEVICE), manufactured by Peritone Research, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code HIR cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K861683 · Peritone Research, Ltd. · Gastroenterology & Urology device
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Jun 1986
Decision
32d
Days
Class 2
Risk

K861683 is an FDA 510(k) clearance for the MONSANTO SANTOPRENE (PERITONE DEVICE). Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Peritone Research, Ltd. (Bellerose, US). The FDA issued a Cleared decision on June 2, 1986 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 884.1425 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Peritone Research, Ltd. devices

FDA 510(k) Submission Details - K861683

510(k) Number K861683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1986
Decision Date June 02, 1986
Days to Decision 32 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 130d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIR Device Classification - Class 2, Special Controls

Product Code HIR Perineometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.